Whether it's a simple thermometer or a sophisticated cardiac pacemaker, the goal of FDA 21 CFR Part 820 Compliance and ISO 13485 international standards is to ensure medical device quality and safety and to reduce, if not prevent, injuries and deaths.
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FDA 21 CFR Part 820 compliance outlines Quality System Regulations (QSR) for medical device manufacturers and importers. ISO 13485, a voluntary quality standard, provides a framework for meeting medical-device quality requirements in the international market.
The MasterControl™ document and quality management suite is an integrated, configurable, and easy-to-use software solution especially designed to facilitate FDA 21 CFR Part 820 compliance and other FDA regulations. Here's how MasterControl can help medical device companies meet key QSR requirements and at the same time increase efficiency and keep compliance costs down. To learn more about 21 CFR Part 820 Compliance, contact a MasterControl representative.